Diagnostics

  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest to offer Fujirebio’s FDA-cleared Alzheimer’s blood test

    The company plans to make the diagnostic available to physicians and researchers this summer, expanding its portfolio beyond laboratory developed tests.

    By • July 15, 2025
  • Becton Dickinson logo
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    Permission granted by Becton Dickinson
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    Waters, BD biosciences unit agree to $17.5B merger

    The BD business will be spun off and merged with a Waters subsidiary. Waters shares were down about 11% in early trading Monday on the news.

    By • July 14, 2025
  • the FDA Headquarters Explore the Trendline➔
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    Sara Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • A head shot of Martin Stumpe, Danaher's chief data and artificial intelligence officer.
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    Permission granted by Danaher
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    Danaher appoints Martin Stumpe as chief technology and AI officer

    The company said Stumpe’s promotion is a “pivotal step in [its] digital transformation and its ambition to lead the next era of innovation in life sciences and diagnostics.”

    By • June 30, 2025
  • EU flags in front of the Berlaymont building, headquarters of the European Commission in Brussels, Belgium.
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    Alxpin via Getty Images
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    MedTech Europe urges EU to exclude devices, diagnostics from trade war

    MedTech Europe said the EU’s list of products it could target in retaliation for U.S. actions “includes over 800 trade codes related to medical technologies.”

    By • June 23, 2025
  • The entrance to Illumina's San Diego campus.
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    Courtesy of Illumina
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    Illumina to buy SomaLogic for up to $425M

    Illumina said adding SomaLogic would support the company’s multiomics strategy and strengthen the value of its NovaSeq X products.

    By • June 23, 2025
  • Medical Science Laboratory with Diverse Multi-Ethnic Team
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    gorodenkoff via Getty Images
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    Could the FDA take an indirect approach to regulate LDTs?

    Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

    By • June 16, 2025
  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest partners with MD Anderson to develop cancer risk blood test

    Quest plans to refine, develop and validate the technology and is aiming to launch the test in North America next year.

    By • June 13, 2025
  • A scientist in blue clothing walks past sequencing machines in a Caris Life Sciences tissue laboratory.
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    Courtesy of Caris Lifesciences
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    Caris Life Sciences plans $424M IPO

    Caris, which offers tools for disease diagnosis, therapy selection and treatment monitoring, is the latest company to test the medtech IPO market.

    By • June 10, 2025
  • blood test tubes
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    Stock via Getty Images
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    Freenome posts pivotal liquid biopsy data as FDA filing nears completion

    Freenome plans to complete all modules of its premarket approval submission in mid-2025.

    By • June 4, 2025
  • A person in scrubs and gloves holds an image of a mammogram above a lighted panel
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    Thomas Andreas via Getty Images
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    Clairity receives FDA OK for breast cancer risk prediction tool

    The startup received de novo authorization for the AI tool, the first of its kind that analyzes mammogram images to predict breast cancer risk over five years.

    By • June 3, 2025
  • Close-up on a scientist using a mobile app on a digital tablet while working at the laboratory
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    Stock via Getty Images
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    FDA declines to appeal court order that stopped LDT final rule

    “The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen analysts wrote.

    By • June 3, 2025
  • An AstraZeneca logo stands atop an office building in Shanghai, China.
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    Robert Way via Getty Images
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    AstraZeneca drug could help keep a common breast cancer at bay

    Data presented at ASCO show that swapping in the oral drug camizestrant for an older therapy helped sustain the benefit of initial treatment, potentially opening a novel step in patient care.

    By Ned Pagliarulo • June 2, 2025
  • HeLa cervical cancer cells are seen stained blue against a yellow background.
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    Heiti Paves via Getty Images
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    Teal posts data on newly approved at-home cancer screening device

    Self-collection correctly identified 95.2% of HPV samples that are associated with increased cancer risk.

    By • May 20, 2025
  • The headquarters of the FDA, which has recently issued a recall for Teleflex air filters used in hospital respirators.
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    Sarah Silbiger/Getty Images via Getty Images
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    FDA clears first blood test to aid Alzheimer’s diagnosis

    The FDA cleared the test for the early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.

    By • May 19, 2025
  • The hand of a scientist in a blue glove runs a test on an Illumina sequencing machine.
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    Courtesy of Illumina
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    SEC ends probe of Illumina’s Grail acquisition

    The DNA sequencing company also cut its 2025 earnings outlook to reflect the impact of tariffs on its business.

    By • May 9, 2025
  • A container ship sits docked at the Port of Oakland on Dec. 9, 2024.
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    Justin Sullivan via Getty Images
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    Earnings & Tariffs

    Danaher predicts $350M tariff hit, moves to mitigate impact on profits

    The company is planning manufacturing footprint changes, supply chain adjustments, surcharges and cost cutting to limit the impact of the tariffs.

    By • April 24, 2025
  • The entrance to Illumina's San Diego campus.
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    Courtesy of Illumina
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    Illumina, Tempus AI partner to drive genomic testing beyond cancer

    The partners plan to build evidence packages that standardize comprehensive genomic profiling and other molecular testing across all major diseases.

    By • April 18, 2025
  • A female hematologist analyzes medical samples at a hospital laboratory.
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    andresr via Getty Images
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    Deep Dive

    A judge blocked the FDA’s plan to regulate LDTs. What now?

    One attorney said the ruling “isn’t quite the stake in the heart.”

    By • April 16, 2025
  • A view of Building 1 at Cepheid headquarters in Sunnyvale, California. Cepheid plans to consolidate manufacturing activities at its Sunnyvale headquarters.
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    The image by Coolcaesar is licensed under CC BY-SA 4.0
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    Cepheid to lay off 167 people in California

    The company laid off more than 1,300 people in California in 2023 and 2024 as respiratory sales fell from the peak hit during the pandemic.

    By • April 14, 2025
  • A computer tomography machine has two screens on the sides showing patient results.
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    Courtesy of GE Healthcare
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    Trump tariffs

    China probes US-made CT tubes after Trump hikes tariffs

    The investigation indicates that China will likely favor local medtech companies over foreign competition amid international economic tensions, a J.P. Morgan analyst said.

    By • Updated April 9, 2025
  • A picture of the exterior of a Labcorp building.
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    Courtesy of Labcorp
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    Labcorp launches blood test to accelerate Alzheimer’s diagnosis

    Manufacturers of Alzheimer’s disease drugs have identified blood tests as a way to accelerate diagnosis and treatment.

    By • April 7, 2025
  • A person wearing gloves hangs a clear bag with fluid on a metal hook.
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    Bevan Goldswain via Getty Images
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    Trump tariffs

    Tariffs send healthcare industry into ‘unchartered waters’

    Provider groups and health systems warn tariffs will test healthcare’s fragile supply chain. Wall Street, meanwhile, said medtech businesses will face pressure, particularly diabetes tech firms.

    By Susanna Vogel , • April 4, 2025
  • A picture of a researcher standing in front of a testing machine in a laboratory.
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    Karen Ducey/Getty Images via Getty Images
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    Texas judge overturns FDA’s lab developed test regulation, siding with industry groups

    The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.

    By • April 1, 2025
  • A flat hand holds up an at-home STI test against a white bakcground
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    Courtesy of Visby Medical
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    FDA OKs first at-home test for 3 STIs

    Visby Medical’s at-home diagnostic, which can be purchased without a prescription, tests for chlamydia, gonorrhea and trichomoniasis.

    By • March 31, 2025
  • 23andMe
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    Justin Sullivan via Getty Images
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    23andMe files for bankruptcy; CEO Anne Wojcicki resigns

    The DNA-testing company plans to sell its assets after the board rejected an acquisition proposal from Wojcicki.

    By • March 24, 2025